Soft tissue coring biopsy devices and methods

ABSTRACT

A biopsy device comprises a coring and transport assembly and a distal beak assembly. The distal beak assembly may be coupled to or near a distal end of the coring and transport assembly and may comprise at least one movable cutting element. The distal beak assembly may be configured to rotate about an axis, and assume at least a first open configuration operative to enable the at least one cutting element to core through tissue and a second closed configuration operative to enable the at least one cutting element to move through the tissue and to sever a cored specimen from the tissue.

BACKGROUND

Embodiments relate to medical devices and methods. More particularly,embodiments relate to single insertion, multiple sample soft tissuebiopsy and coring devices and corresponding methods for retrievingmultiple soft tissue biopsy samples using a single insertion.

SUMMARY

Embodiments are drawn to various medical devices and methods that areused for core biopsy procedures. According to one embodiment, a biopsycoring/delivery device may be configured to retrieve multiple samples ofnormal and/or abnormal appearing tissues during a single insertionthrough the skin (percutaneous procedure) into the, for example, softtissue area of the body from which the biopsy is taken. Embodiments maycomprise structures and functionality for different phases of amulti-phase biopsy procedure. For example, embodiments may comprise apre-treatment of the area and/or of the abnormal tissue, or the deliveryof tracer materials for tracking the potential spread or flow patternswhereby the abnormal tissues (such as cancerous tissues) maymetastasize. Embodiments may also comprise an intra-procedure deliveryof medications that may anesthetize tissues at the site, or the deliveryof other therapeutic agents such as pro-coagulants and others, as wellas delivery of post-procedure materials such as medications, implantablematerials for cosmetic purposes and other implantable elements such asmarking devices for later imaging reference. Embodiments of a biopsydevice, along with associated related subcomponents described herein,may provide the capability to retrieve solid, contiguous and/orfragmented tissues as well as liquid and semi-solid tissues foranalysis, diagnosis and treatment. Embodiments may be configured to beportable, disposable or reusable and may be electrically, mechanicallyand/or manually powered and operated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a core biopsy device according toembodiments;

FIG. 2 is a perspective view of a core biopsy device according to oneembodiment;

FIG. 3 is a side view of the core biopsy device of FIG. 1, showinginternal components thereof, according to embodiments;

FIG. 4 is a perspective view of a beak assembly of the core biopsydevice of FIG. 1 in an open, coring and/or delivery position, accordingto embodiments;

FIG. 5 is a top view of a beak assembly of the core biopsy device ofFIG. 1 in a closed, penetration or part-off position, according toembodiments;

FIG. 6 shows the cutting, sharp cutting elements of a beak assemblyengaging a core sample, according to one embodiment;

FIG. 7 is a side view of a beak of a core biopsy device according to oneembodiment;

FIG. 8 is a side view of a beak of a core biopsy device according to oneembodiment;

FIG. 9 is a side view of a beak of a core biopsy device according to oneembodiment;

FIG. 10 is a side view of a beak of a core biopsy device according toone embodiment;

FIG. 11 is a side view of a beak of a core biopsy device according toone embodiment;

FIG. 12 is a side view of a beak of a core biopsy device according toone embodiment;

FIG. 13 is a side view of a penetration/coring/part-off/delivery beak ofa core biopsy device in a closed, penetration or part-off position aswell as a superimposed, open coring and/or delivery position with hingeassemblies as shown, according to one embodiment;

FIG. 14 is a side view of one beak element of apenetration/coring/part-off/delivery beak of a core biopsy device in anopen coring and/or delivery position, according to one embodiment;

FIG. 15 is a side view of a non-rotating or differentially rotatingouter tubular element of a core biopsy device and a section forinteracting with a beak assembly (including, for example, elements 13),according to one embodiment;

FIG. 16 is a side view of a penetration/coring/part-off/delivery beakassembly of a core biopsy device of FIG. 1 with one beak element in aclosed, penetration or part-off position, with its inner element shownin dash lines, and another beak element in an open coring and/ordelivery position with its inner element hidden by an outer sheath tube,and hinge assembly, according to one embodiment;

FIG. 17 is a side view of a beak assembly of a core biopsy device in afirst closed configuration, with an additionalcoring/transport/supporting element, according to one embodiment;

FIG. 18 is a side view of a beak assembly of a core biopsy device in asecond midway open configuration, with an additionalcoring/transport/supporting element, according to one embodiment;

FIG. 19 is a side view of a beak assembly of a core biopsy device in athird open to coring and/or delivery positions, with an additionalcoring/transport/supporting element, according to one embodiment;

FIG. 20 is a side perspective view of a beaks assembly of a core biopsydevice according to one embodiment;

FIG. 21 is a side perspective view of a beaks assembly of a core biopsydevice according to one embodiment;

FIG. 22 is a side perspective view of a beaks assembly of a core biopsydevice according to one embodiment;

FIG. 23 a is a side view of fixed and hinged beaks of a beak assemblyaccording to one embodiment, in an open configuration, along withopening and closing actuating components, as well as hinge and pivotpoints;

FIG. 23 b is a side view of fixed and hinged beaks of a beak assemblyaccording to one embodiment, in a closed configuration, along withopening and closing actuating components, as well as hinge and pivotpoints;

FIG. 24 is a close up side view of a driving mechanism for components ofbeak actuation elements of a biopsy device, as well as a drivingmechanism for a vacuum assisting element and a rack-and-pinion rackelement of the present biopsy device, in addition to a motor driveelement of the present biopsy device, according to one embodiment;

FIG. 25 is a side view of phases of drive element relationships used toactuate beak elements of a biopsy device, according to one embodiment;

FIG. 26 is a side view of phases of drive element relationships used toactuate beak elements of a present biopsy device, according to oneembodiment;

FIG. 27 is a side view of phases of drive element relationships used toactuate beak elements of the present biopsy device, according to oneembodiment;

FIG. 28 is a side view of a non-rotating or differentially rotatingouter tubular element of a core biopsy device and a section interactingwith (a) beak assembly of FIG. 14, as well as supplemental actuationaugmenting rod element(s) of the present biopsy device, according to oneembodiment;

FIG. 29 is a side-perspective view of a non-rotating or differentiallyrotating outer tubular element of a core biopsy device and a sectioninteracting with a beak assembly, as well as supplemental actuationaugmenting rod element(s) of present biopsy device, according to oneembodiment;

FIG. 30 is a side view of a core biopsy device showing internalcomponents including a transport helical element, power supply, motordrive unit, augmenting vacuum elements and an external power supply plugin socket, as well as an on/off switch element, according to oneembodiment;

FIG. 31 is a top view of a core biopsy device, showing internalcomponents including a transport helical element, drive gears foractuating beak elements as well as a pulley and belt system and elementsof a storage tube magazine with fenestration elements, as well as amovable guiding element, according to one embodiment;

FIG. 32 is a side view of a non-rotating or differentially rotatingouter tubular element of a core biopsy device, and a section such as aninternal helical transport/delivery mechanism, in relationship with (a)non-rotating or differentially rotating outer tubular element(s) of abiopsy device, according to one embodiment;

FIG. 33 is an end on, perspective view of a non-rotating ordifferentially rotating outer tubular element of a core biopsy device,showing an internal surface configuration, and a section such as aninternal non-rotating or differentially rotating inner helicaltransport/delivery element in relationship together, of the presentbiopsy device, according to one embodiment;

FIG. 34 is an end on, perspective view of a rifled internal surfacesegment of a non-rotating or differentially rotating outer tubularelement with a view of an comprised internal non-rotating ordifferentially rotating inner transport/delivery helical element of acore biopsy device, according to one embodiment;

FIG. 35 is an end on, perspective view of yet another internal surfaceconfiguration of a non-rotating or differentially rotating outer tubularelement with a view of an comprised internal non-rotating ordifferentially rotating inner transport/delivery helical element of acore biopsy device, according to one embodiment;

FIG. 36 is a side view of a non-rotating or differentially rotatingouter tubular element of a core biopsy device, and a section such as anon-rotating or differentially rotating internal helicaltransport/delivery mechanism, in relationship with an a additionalnon-rotating or differentially rotating internal helicaltransport/delivery element, according to one embodiment;

FIG. 37 shows two side views and a top view of a biopsy device, with aninternal carriage that moves to a distance or could move within suchboundary 180 holding internal components, according to one embodiment;

FIG. 38 is a side and top view of a biopsy device, with an internal,movable, excursion-modifying assembly (stage/carriage) 190 of componentsof the present biopsy device, in this case carrying additionalcomponents vacuum/delivery assembly 140, according to one embodiment;

FIG. 39 is a side view of a biopsy device, showing a vacuum/deliveryassembly 140 of FIG. 31, a connecting tube and valvular assembly, aswell as an additional connecting tube and in-line valve component, inaddition to a collection receptacle, according to one embodiment;

FIG. 40 is a side view of a biopsy device, showing a connected cartridgecontaining pellets in its barrel, according to one embodiment;

DETAILED DESCRIPTION

Reference will now be made in detail to the construction and operationof preferred implementations of the embodiments illustrated in theaccompanying drawings. The following description is only exemplary ofthe embodiments described and shown herein. The embodiments, therefore,are not limited to these implementations, but may be realized by otherimplementations.

Core biopsy procedures have evolved from simple core needle biopsiescomprising aspiration of fluids using a simple syringe and needle todevices having the capability to extract solid tissues forhistopathological analysis. This more recent capability has proved to bea far more powerful way to diagnose diseases and abnormal tissueentities, some of which are extremely life threatening, and others whichmay be more benign but nevertheless must be definitively distinguishedfrom the more dangerous types of abnormalities, including cancerous andpre-cancerous lesions, in-situ cancers, invasive cancers, benign spaceoccupying lesions, cystic lesions and others. As core biopsy procedureshave evolved into far more diagnostically powerful tools, they havedisplaced many of the more invasive open surgical procedures, which hadbeen and continue to be performed for diagnostic purposes, based on theadvantages of retrieving a sufficient volume of tissue with thepreserved architecture that is so critical in the diagnosis andtreatment algorithm used by clinicians in addressing these abnormalitiesand diseases. One of the most critical needs during a biopsy procedureis to accurately correlate tissue diagnosis with imaging diagnosis. Inorder to successfully accomplish this, it is essential to know that theretrieved tissue actually and accurately represents the imagedabnormality. This is an aspect where many conventional coring devicesfall short. For this reason, open surgical diagnostic procedures andother invasive procedures continue to be performed. Other clinicallysignificant limitations of these procedures include the manner in whichthe abnormal tissue is separated from the host organ, the manner inwhich the tissue is retrieved and handled during the process by thecoring biopsy device, and the amount of biopsy artifact/damage impartedto the tissue specimens by the coring procedure and device. Yet anotherconsideration in the design of improved coring devices is the existenceof an important tradeoff among conventional coring biopsy devices. It iswell known that the larger the caliber of the retrieved tissue samples,the better the correlation with the imaging abnormality, and thus theeasier, more accurate, definitive and helpful the diagnosis. However, inorder to retrieve larger caliber specimens, most biopsy devices havelarge outer diameters, leading to increased trauma, complications, painand other adverse effects, due principally to the imprecision associatedwith such large bore devices. Additionally, tracking a large bore devicethrough the tissues is much more difficult, particularly without thehelp of an active mechanism to aid in smoother and more gradualadvancement of the biopsy device. The larger the caliber of the biopsydevice, the more difficult it becomes to precisely visualize the biopsydevice in relation to the target abnormality, especially for smalllesions (on the order of about ½ cm to less than ¼ cm). Today, more than4-5 million diagnostic core biopsies are performed each year around theworld in the breast alone, with as many as 2 million diagnostic breastbiopsies being performed each year in the US. There is little doubt thatmany invasive, open surgical diagnostic biopsies should be replaced byimproved core biopsy procedures. Moreover, there is a need to improveupon existing core biopsy procedures and devices by eliminating thewell-known limitations of current devices.

Reference will now be made in detail to the construction and operationof preferred implementations illustrated in the accompanying drawings.FIGS. 1 and 2 show a biopsy device 10 according to embodiments having atubular coring and transport assembly 11 of appropriate dimensions toretrieve a single or multiple core samples of tissue (not shown) thatis/are sufficient to provide the desired clinical diagnostic ortherapeutic result. Such an appropriate dimension may be, for example,about 4 and ½ inches in length, in addition to a forward excursion ofthe tubular coring and transport assembly 11 during the coring phase. Itis to be understood, however, that the foregoing dimensions and anydimensions referred to herein are exemplary in nature only. Those ofskill in this art will recognize that other dimensions and/orconfigurations may be implemented, depending upon the envisagedapplication, and that the tubular coring assembly could be of anylength, and may be configured to be bendable so as to define a curve.One embodiment of the biopsy device 10, as shown in the figures, may beimplemented in a hand-held configuration comprising an ergonomicallycomfortable and secure handle 12 at its proximal end from which thetubular coring and transport assembly 11 extends so that the biopsydevice 10 may be easily directed with one hand while the other hand isfree to hold a guiding probe such as an ultrasound transducer (shown inFIG. 2). However, it is to be understood that embodiments may readily beconfigured to fit onto any number of guiding devices such as astereotactic imaging stage or other guidance modality (not shown). Asshown, one embodiment of the biopsy device 10 may comprise a pluralityof sharp, rotating cutting elements 13 (herein, alternatively andcollectively referred to as “beak”, “beak assembly” or “beak element” or“beak elements”) projecting forward distally from the distal free end ofthe tubular coring and transport assembly 11 for the purpose of forwardpenetration, coring and/or parting off of the core sample. The tubularcoring and transport assembly 11 may comprise a plurality of components,which plurality of elements may be configured to transmit rotationalmovement to the rotating or non-rotating cutting elements 13. It is tobe understood that the “tubular” description of the coring and transportassembly may be of any cross section shape and size, of any length. Thecomponents of the tubular coring and transport assembly 11 (not allcomponents being visible in FIGS. 1-2) also transfer the core sampleback proximally along the internal length of the tubular coring andtransport assembly 11 to the handle 12 and storage compartment (notshown). According to one embodiment thereof, the biopsy device 10 maycomprise a handle or handle 12, which handle or handle 12 may compriseand/or be coupled to mechanical components (not shown) needed to drivethe coring/transport/part-off/delivery distal tubular coring andtransport assembly 11. As shown, one embodiment may comprise adistally-disposed beak 13 that may comprise one or more sharp cuttingtip blades configured to penetrate to the target site 15 of the intendedbiopsy, core the target tissue and part-off or cut off the core sample(not shown) at its base. The handle 12 may also be coupled to and/orcomprise the mechanical components needed to drive the transportmechanism within the distal tubular coring and transport assembly 11 andalso within the handle and through to a storage magazine (not shown)attached to the proximal end of the handle 12. The ability of thepresent biopsy device to repeatedly core and retrieve multiple samples(not shown) during a single insertion, store the cored samples in amagazine (not shown) means that with a single penetration through theskin of, for example, a human breast 16, the operator can samplemultiple areas without causing additional trauma that would beassociated with having to remove the biopsy device 10 each time a sampleis taken, and reintroducing the biopsy device 10 back into the patientto take additional core samples. The handle 12 may also contain and/orbe coupled to (internal or external) mechanical components (not shown)for augmentation vacuum fluid evacuation as well as the delivery ofmaterials such as a variety of medications, tracer materials and/orimplantable marker elements (not shown here). The distal or tubularcoring and transport assembly 11, according to one embodiment, may beconfigured such as to create the smallest possible caliber (e.g.,diameter) of coring tube (tubular coring and transport assembly 11) witha range of (for example) about 16 gauge to about 10 gauge diameter,while providing a sufficiently large diameter of core sample to beclinically useful. The tubular coring and transport assembly 11 may alsobe of a sufficient length to reach distant target sites such as, forexample, about 4 and ½ inches (11 centimeters) from the skin surfacewithout the need for a surgical procedure to enable the distal end (thatend thereof that is furthest from the handle 12) of the biopsy device 10to reach the targeted site. As shown in the embodiments of FIGS. 1 and2, the distal tubular coring and transport assembly 11 of the biopsydevice 10 may extend distally from the handle 12 a distance sufficientto create a core (not shown) of usable length for diagnosis and/ortreatment purposes. As is described below, this distance of forward ordistal projection can be selectively changed at will, thanks tostructure configured for that purpose, which may be built into orotherwise coupled to the present biopsy device 10. Embodiments of thepresent biopsy device 10 may be used by right and/or left handed personsand in multiple positions (including upside down for example) andorientations (different angles), so that in areas of limited access, thepresent biopsy device may still be easily positioned for idealorientation to perform a biopsy procedure under real time or other imageguidance (not shown). The entire device may be configured to bedisposable or may be configured to be reusable in whole or in part.Embodiments of the present biopsy device 10 may be electrically poweredby one or more batteries (not shown) stored, for example, in the handle12 and/or external power sources (not shown) through a simple electricalcoupling (not shown) to connect to an external power supply convenientlyplaced, for example, in the handle or proximal end of the present biopsydevice. The biopsy device 10 may alternatively in whole or in part, bepowered by mechanical energy (provided, for example, by compressed airmotors, by watch-type springs, or manually by the operator). In FIGS.1-2, the biopsy device 10 is shown in a coring configuration with thedistal end thereof open for coring, and in a configuration in which itmay be partially projecting forward from the proximal handle 12, fromits resting position with a portion of the tubular coring and transportassembly 11 extending slightly distally along the first part of itsforward excursion. In this view, the biopsy device 10 is shown with acombination switch 14 to activate and/or physically move variousinternal components (not shown).

FIG. 2 is a perspective view of the core biopsy device according to oneembodiment, with the distal tip (comprising the beak assembly) of thebiopsy device in position inside an organ such as a breast, a targetlesion, an ultrasound probe on the surface of a breast, and rotatingcutting and coring beak assembly in an open position, according toembodiments. FIG. 2 shows the coring biopsy device 10 pointing at atarget lesion 15 within breast tissue 16, as visualized under anultrasound guiding probe, shown at reference numeral 17. The presentbiopsy device's tubular coring and transport assembly 11 is shownpictorially as if moving in an axially forward direction with itsdistally placed, sharp cutting tip blades of the beak 13 open androtating for coring.

According to one embodiment, a method of carrying out a biopsy proceduremay comprise imaging the tissue of the organ (such as the breast) ofinterest and identifying the target lesion(s). The skin may then becleaned using sterile techniques, the patient may be draped andanesthetics may be delivered. The distal tip of the present biopsydevice may then be introduced through a skin nick. For example, apenetration mode may be activated, in which the distal beak may becaused to assume a closed beak configuration. The distal beak 13 may becaused to rotate to facilitate penetration through the tissue. Thedistal beak 13 may then be advanced toward the target lesion and maythen be caused to stop just short (e.g., 2-4 mm) of the nearest edge ofthe target lesion. A stage may then be initiated in which the distalbeak 13 may be caused to assume an (e.g., fully) open configuration andthen stopped. An optional delivery stage may then be initiated, todeliver, for example, the contents of a preloaded cartridge such astracer elements like visible dyes, echo-enhancing materials and/orradioactive tracer elements or others such as medications (which may bedelivered at any stage of the biopsy procedure). After or instead ofoptional infection stage, a coring stage may be initiated while holdingthe biopsy device handle steady and/or actively redirecting the distalbeak as desired. The coring may then continue, in either an automatic orsemiautomatic mode. During the coring stage, the carriage movementfunction may be engaged to either elongate or shorten the axialexcursion of the coring elements as desired to achieve acceptable ordesired tissue margin collection at both ends of sample, or to avoidunwanted coring into adjacent tissues, or simply to obtain differingcore sample lengths for later correlation with various stages of thedocumented procedure. During one or more of the cornings, a record stagemay be activated to halt the coring stage just after the specimen hasbeen parted-off in order to enable the practitioner to record image(s)of the shaft of the biopsy device in place in the lesion, to documentthat core samples (particularly those of different chosen lengthsobtained serially during the procedure) were acquired precisely fromimaged lesions. Upon completion of the biopsy procedure and, if desired,prior to removal of the device, a specimen ultrasound or a radiographmay be carried out upon the specimens collected within the storagemagazine, which may be especially configured for echo and radio lucencyas well as MRI-compatibility. The removable magazine may then be placedinto a receptacle preloaded with preservative and sealed, and ifdesired, a replacement magazine may be loaded into the device tocontinue the biopsy. Following the acquisition of a sufficient number ofcore samples and following the documentation stage, the core sampleacquisition site may be firmly correlated with the image abnormalitylocation. If so attached, the liquid aspirate storage vessel may then beremoved and capped securely for transport to an appropriate laboratoryfor cellular and subcellular analysis. Alternatively, still with thebiopsy device in place, the tissue storage magazine may be removed,which may be replaced with an injection cartridge that may be pre-loadedwith post-biopsy elements such as medications, cosmetic implants,brachytherapy elements, and the like. The present biopsy device may thenbe removed from the site and the wound may then be dressed, with theusual standard of care procedures. It is to be understood that the abovedescription is but one exemplary methodology and that one or more of thesteps described above may be omitted, while other steps may be addedthereto. The order of some of the steps may be changed, according to theprocedure.

FIG. 3 shows a side internal view of a coring biopsy device 10,according to one embodiment. As shown, two internal components of thepresent biopsy device's tubular coring and transport assembly 11 areshown; namely, a non- or differentially rotating outer tubular element25 of the transporting mechanism and a more internally placed (also non-or differentially rotating) helical component 26 extending from thesharp cutting tip blades of beak 13 proximally back through the handle12 and ending in overlapping manner inside or outside up to the openingof a storage magazine 27. Also shown are a battery power source 28 andan electrical driving motor assembly 29 including gearing configured torotate and axially displace the components of the tubular coring andtransport assembly 11. In the embodiment illustrated in FIG. 3, anactivating switch 30 is shown in position at the forward, topsideportion of the handle 12, it being understood that the placement andstructure thereof may be freely selected. An augmenting vacuum/deliverymechanism may also be provided, as shown at reference numeral 31, whichmay also be driven by the driving motor assembly 29 during coring andtransport of the core tissue specimens (not shown). Also shown in FIG. 3is a power coupling or jack 32, configured for connection to an externalpower source (not shown).

FIG. 4 shows a close up perspective view of sharp cutting tip bladesemerging from the distal end of the tubular coring and transportassembly 11, which may be advantageously configured, according to oneembodiment, to have a beak-like shape. The forward and side edges 40 and41 of the blades may be sharpened such that they are able to cut tissueswhile the beak assembly rotates, while moving distally in an axialdirection with respect to handle 12, and/or while opening away from andthen, in sequence, closing down against one another to part-off or severthe core sample (not shown). The cutting tips/blades of beak assembly 13may be opened as far apart as desired. However, for illustrativepurposes, they are shown in FIG. 4 as being opened to a position thatmay be characterized as being roughly parallel to the rest of thetubular coring and transport assembly 11 (not shown in FIG. 4). Theshape of these cutting tip blades of beak assembly 13 may beadvantageously selected such that when closed, they completely occludealong their forward 40 and side 41 edges. However, the cutting tipblades of beak assembly 13 need not completely contact one another alongthe entire edges in order to effectively core and sever or part-off thebase attachment end of the core sample (not shown), as, for illustrationpurposes only, if the beaks are rotating or moving axially whileclosing. The shape of the sharp cutting elements of beak assembly 13 maybe formed, for example, by straight angle cutting of a tube such asstainless steel hypo-tube, similar to the way a hypodermic needle ismade, but with a significant differentiator; namely, that the cutting ofthe elements of beak assembly 13 may be advantageously carried out suchthat the first angle or bevel cut is stopped at the halfway point alongthe cut, once the midway point across the tube diameter is reached.Then, beginning from the opposite sidewall of the tube, anotheridentical cut is made at the same angle and beginning in the same planeand starting point. This cut ends where it would meet the initial cut(if using the same raw stock tube for example). In this manner, theedges of the cutting tip elements would perfectly occlude and close offcompletely with one another all along the forward 40 and side 41 cuttingsurfaces, while in the closed, part-off/severing position (not shown).According to an embodiment, a method for shaping the sharp cuttingelements of beak assembly 13 may comprise an additional angle or bevelcut away from the sharp tip end of the cutting element. This cut beginsmore near the sharp tip end than straight across the diameter of the rawstock tube or hypo-tube stock. The purpose of beginning this cut“downstream” towards the tip is so that in closed position, the distancechosen permits the closed elements of beak assembly 13 to close downwithout their bases extending outward beyond the diameter of the tubefrom whence they were taken—which may be about the same diameter ofother components of biopsy device 10, such as the outer non- ordifferentially rotating outer tubular element 25. It may also beadvantageous to cut the cutting tip elements from a tube of slightlylarger diameter than the other components of the present biopsy deviceto achieve shapes that would still comprise all of the functionality ofthe design, but also comprise a feature such as a “springiness” tosimplify the hinge mechanisms in nested form, simplify construction,allow additional tip base configurations, or allow steeper angles forthe cutting tip in closed configuration or to allow the beaks to open tosuch a degree that the cutting radius of the beak tips exceeds the outerdiameter of the outer tubular element 25. Such inherent springinesswould also improve the stiffness of the cutting tips in a radialdimension, which may facilitate easier penetration of dense tissues. Thebase cut may, however, comprise a flap (and thus require a slightly morecomplex cut to create a slightly more detailed shape to comprise acontiguous section that may be formed into a hinge as described (notshown) above that may later be made into a hinge (such as is shownbelow, with respect to hinge assembly 50 in FIG. 24).

The shape of the sharp cutting elements beak assembly 13, such as theembodiment thereof shown in FIG. 4, for example, provides substantialsupport vectors for all movements required of the cutting blades duringrotation, opening/closing and axial motions (not shown). This embodimentenables the sharp cutting elements of beak assembly 13 to be madeextremely thin, which fulfills a requirement that for any given outerradial dimension of the tubular coring and transport assembly (includingthe cutting beak assembly) 11 (see also FIG. 1), the caliber of the coresample retrieved from the patient will be a large as possible. Inaddition, were the sharp cutting elements of beak assembly 13 insteadformed of a cone-like shape, they would not, when wide open and roughlyparallel to the long axis of tubular coring and transport assembly 11,core a full diameter sample, since the conical taper progressing towardsthe tip would be of ever diminishing radius compared with the tubularcoring and transport assembly 11, which is prepared to receive the coresample. The shape(s) of the sharp cutting elements of beak assembly 13specified for use in coring and part-off according to embodiments enablethe biopsy device 10 to core a full diameter (and in fact larger thanfull diameter with respect to the dimensions of the coring and transportassembly 11, of which slightly larger caliber (e.g., diameter) may bedesirable in order to compress, “stuff” or pack in as much tissue sampleinto the tubular coring and transport assembly 11 as possible), whichmay prove advantageous from several standpoints (including diagnostic,clinical standpoints) or provide more sample (not shown) for analysis.

FIG. 5 shows a top view of the sharp cutting elements of beak assembly13, according to one embodiment. In this view, a hinge assembly 50(which may have been formed continuous with the rest of the piece,using, during construction, a slightly more complex cut from the rawtube stock as described above) is shown at the proximal junction pointof the sharp cutting elements of beak assembly 13 with the non- ordifferentially rotating outer tubular element 25 of a tubular coring andtransport assembly 11 (shown in FIG. 1). The hinge assembly 50 mayinteract with a raised rim section 51, or with other attachment methodthat permits differential rotation of the outer tubular element 25, sothat the beak assembly 13 may rotate independently of the outer tubularelement 25 of the tubular coring and transport assembly 11. It is to beunderstood that this hinge assembly may also be fixed to the outertubular element 25, and thus rotate the beak assembly contiguously withthe outer tubular element. This hinge assembly 50 may have sharpenededges 52 so that they encounter minimal resistance in the tissue duringrotational and other movements. This design feature may also serve to“core” a slightly larger diameter within the tissue during “closed beakpenetration” mode, so that the tubular coring and transport assembly 11may move with less resistance within the tissue environment on the wayto the target lesion or tissue harvesting site. The constituent elementsof the hinge assembly 50 may also be slightly angled so that, duringrotation, they provide a “screw” type effect, helping to pull the outerdiameter of the shaft (tubular coring and transport assembly 11) throughthe dense tissues that are often encountered in breast tissue 16 (shownin FIG. 2) or other tissue found in the body, on approach to targetlesion 15 (also shown in FIG. 2).

Clinically and procedurally, the ability of a biopsy device to advancegently towards a target lesion provides several advantages. Indeed, whena biopsy device does not advance gently toward a target lesion or doesnot smoothly core through dense target tissue, the operator may be ledto exert excessive force onto the biopsy device, thereby potentiallyforcing the biopsy device into and even through adjacent structures.There have been instances of biopsy device components being broken off,requiring surgical removal thereof from the biopsy site when excessiveforce was needed in attempts to obtain core samples from tissues such asdense breast tissue 16 (the density characteristics of the breast tissue16 not illustrated in FIG. 2). The present method of powered, closedbeak penetration mode in one embodiment herein and provided for with aspecific cycle stage in the biopsy device 10 of FIG. 1, enables anoperator to gently and smoothly approach a target lesion such as shownat 15 in FIG. 2, without requiring excessive manual axially-directedforce to be exerted on the present biopsy device by the operator. It isto be noted that when excessive force must be exerted to advanceconventional coring devices through dense tissue, the resultant imageprovided by guidance modalities (such as ultrasound) may besignificantly distorted by the force applied to the conventional coringdevice and transferred to the surrounding tissue. This force may damagetissue, resulting in loss of tissue architecture and production of theaforementioned biopsy artifact, and may also cause the resultant imageto be less distinct or blurred which, in turn, makes the biopsyprocedure less accurate and much more difficult technically. It is animportant goal of all core biopsy procedures to firmly establish thatthe core sample is taken from the highly specific image area,notwithstanding the constraints imposed by the small dimensions of thetarget tissue. Such small dimensions, therefore, require clear views ofsharp margins to attain the kind of accuracy desired.

Keeping the foregoing in mind, embodiments provide the operator withmethods and mechanisms to gently approach and core a target lesion withminimal physical, manual force, thus freeing the operator to focus onthe (often minute) structures to be sampled. In core biopsy procedures,it is highly useful to capture a small amount of normal surroundingtissue still attached to the abnormal tissue, at the junction therebetween, and on both ends of the core sample. The present devices andmethods provide an opportunity to accurately measure the size of anabnormality optically, for example, under microscopic analysis. Theembodiment of the core biopsy device may be configured to gentlyapproach the target lesion 15 in a closed beak configuration (i.e., aconfiguration substantially as shown in FIG. 5), stopping just short oftarget lesion 15, then proceeding to an open beak configuration (i.e., aconfiguration substantially as shown in FIG. 4), coring a small bit ofnormal adjacent tissue, continuing through lesion 15 to the distal sidethereof and coring a small amount of normal tissue on the other side ofthe lesion 15 as well, still controllably within surrounding host tissuesuch as breast tissue 16. Though not illustrated here, the hingeassembly(ies) 50 may also interact with a flared outward/flared inwardcircumferential inner surface of the outer tubular element 25 for thepurpose of providing a hinge assembly for the rotating, cutting, sharpcutting elements of beak assembly 13. As shown, the rotating, cutting,part-off beak assembly 13 may have additional shapes such as a morepointed end as shown (arrow at reference numeral 53) at the forward tip,and/or may have serrations along one or more edges to facilitatecutting, part-off, opening and/or closing. The rotating, cutting,part-off beak assembly 13 may also have a more tapered (steeper orshallower angles) shape as required by the confines of and resistance ofthe materials in which they are designed to operate. Such differentshapes (including asymmetric shapes) and sharpened tips (such aspoint(s) 53) are considered to be within the scope of the presentembodiments. Embodiments, including the beak assembly 13, may beconfigured to enable the coring of full diameter samples and theparting-off of the cored full diameter sample. Embodiments may befurther configured for closed and/or open beak penetration throughtissue and for transporting the core sample (slightly larger diametercores, tapered ends for streamlined passage of cores, etc.,) among otherfunctions. Embodiments may also be configured for open beak coring to atarget tissue, enabling a gentle “core to the lesion” operation where aclinician desires to have a clear reusable track to a target tissue forfuture treatment options. Embodiments also comprise structure andfunctionality configured to enable the ejection and deposition oftherapeutic and/or diagnostic elements and/or substances in the openbeak configuration for precise deposition thereof within the area of abiopsy site.

FIG. 6 shows the coring, sharp cutting elements of beak assembly 13engaging a core sample 60. This figure also may represent the coring,sharp cutting elements of beak assembly 13 in the open position,delivering an in-situ marking element, by ejecting the marking element60 via the coring and transport assembly 11 of the present biopsy device10. Alternatively still, the element 60 may represent some othertherapeutically-active element, such as a radio-active seed forbrachytherapy, or a porous element loaded with a biologically activesubstance.

FIGS. 7-12 show a beak of the core biopsy device of FIG. 1 in varioussequential stages ranging from closed to midway open to fully opencoring and/or delivery positions, as well as next stages progressingfrom fully open to midway closed to fully closed part-off and/or closedpenetration positions, according to embodiments. Indeed, FIGS. 7-12illustrate various phases of operation and functionality of componentsof the coring biopsy device of FIG. 1, according to embodiments.Specifically, FIG. 7 illustrates a side view of the phase of rotationand forward or distal axial movement of the tubular coring and transportassembly 11 and attached cutting elements of beak assembly 13 in aclosed configuration, as well as additional hinge assembly(ies) 70connected to protruding element(s) 71 of an inner tubularelement/helical element 26 of the tubular coring and transport assembly11. FIG. 8 is a side view of partially opened, rotating and axiallyforward shifting, cutting elements of beak assembly 13 as they open toforward/spiral-outward core a tissue specimen (not shown) and/or todeliver materials (not shown) into the tissue. Illustrated in FIG. 8 aredetails of the interactions between the elements of the beak assembly13, hinge assemblies 50, the non- or differentially rotating outertubular element 25 of the tubular coring and transport assembly 11 aswell as distally protruding elements 71 of an inner rotating tubularand/or helical delivery component 26 of the tubular coring and transportassembly 11, which serve to open the beak assembly 13 due to thechanging plane of the hinge assemblies contacting the outer tubularelement 25 with respect to the points contacting the protruding elements71 of the inner component 26 of the tubular coring and transportassembly 11. FIG. 9 illustrates a widely open phase of the tubularcoring and transport assembly 11 and the cutting beaks 13, furthershowing the changing planes 72 of the hinge assemblies 70 and 50 so asto actuate the cutting elements of beak assembly 13. It should be notedthat rotation and axial movement of the cutting elements continuethroughout these as well as the next illustrated phases, as shown inFIGS. 10, 11 and 12.

FIGS. 10, 11 and 12 show the phases of wide-open coring/delivery (FIG.10), followed in sequence by spiraling, closing down movement of thebeak assembly 13 during rotation and axial movement of these elements,as well as components of the tubular coring and transport assembly 11.FIG. 12 shows the position that leads to a complete severing of the coretissue specimen (not shown) from its base connection point with the hosttissue, by the cutting, part-off beak elements 13 of the tubular coringand transport assembly 11, according to one embodiment.

FIGS. 13, 14 and 15 illustrate various hinge assembly alternativedetails for the interaction between the cutting elements of beakassembly 13 and the other components of the tubular coring and transportassembly 11, for the purposes of actuating the cutting elements of beakassembly 13, according to further embodiments. FIG. 13 shows anembodiment in which the hinge assembly or assemblies 50 are displacedinwardly during forward pivoting and movement, with respect to the hingeassemblies 70. In this embodiment, the rotating helical transportelement 26 may be used to move the hinge assemblies 50 while anadditional rotating inner component (not shown) placed in radialposition between the outer non- or differentially rotating outer tubularelement 25, may be used to anchor the hinge assembly(ies) 70. FIG. 14shows another embodiment in which the hinge assembly(ies) 50 of thecutting beak assembly 13 are secured in plane by the outer, non- ordifferentially rotating outer tubular element 25, while hingeassembly(ies) 70 protrude distally to open then retract back proximallyto close the cutting elements of beak assembly 13, which may beconfigured to rotate while moving outwardly, distal-axially to open, andwhich move inwardly to close down under rotational, axial motion. Suchmovements may be either directed distally and/or proximally, dependingon the particular phase of the entire cycle of operation of the presentbiopsy device. Advantageously, locating hinge assemblies 50 as shown inFIG. 14 enables the outer diameter of the cutting elements of beakassembly 13 to be precisely controllable and reliably located. Suchhinge assemblies 50 enable the cutting elements of beak assembly 13 tonot exceed (any more than is desirable), the outer diameter of the moreproximal coring/transport outer tubular element 25. Yet, the cuttingelements of beak assembly 13 may be configured to enable them to hingesufficiently inward to occlude and part-off/sever the core sample at theend of each coring cycle. FIG. 14 also shows an embodiment thatcomprises an inner helical transport coring element 26 of a tubularcoring and transport assembly 11 within the outer non- or differentiallyrotating outer tubular element 25 of the tubular coring and transportassembly 11. This helical element 26 may be configured to terminate in acollar section 80 which may attach to (a) protruding element(s) 71 thatserve(s) as anchoring hinge assemblies 70 for rotating, cutting beakassembly 13 of the biopsy device of FIG. 1. The differential movement ofthe planes of hinge assemblies 70 with respect to hinge assemblies 50results in opening and closing of cutting beak assembly 13, in correctprecise timing such that the functions called for in each stage of thecoring/biopsy cycle are fulfilled.

FIG. 15 shows details such as examples of flaring, tapering surfaces 81of an outer non- or differentially rotating outer tubular element 25 ofthe tubular coring and transport assembly 11, which may serve as alocating rim 81 with which to actuate hinge assembly(ies) 50 of thecutting beak assembly 13, as outer tubular element 25 and hinge assembly50 move together axially relative to hinge assembly(ies) 70.

FIG. 16 shows one embodiment including one cutting beak element 13 in aclosed position, while an additional cutting beak element 13 a is shownin wide-open position to illustrate the relative positions of the hingeassemblies 50 and 70. In this representation, further details of hingeassembly(ies) 70 are shown, with axial and radial positions constrainedsufficiently by a slot element 90 or some other configuration such as atrough configuration, within an inner forward collar section 80 of ahelical coring/transport element 26 of the tubular coring and transportassembly 11. These elements together act to rotate the beak assembly 13and also to move the hinge assemblies 70 in an axial direction distallyand proximally relative to hinge assembly(ies) 50 to actuate opening andclosing of the cutting beak assembly 13 in the various phasesillustrated previously.

FIGS. 17, 18 and 19 show a configuration with a forward cutting edge ofan additional cutting, tubular component 101 of an innercoring/transport helical tubular transport assembly 102, according tostill further embodiments. In this case, the cutting beak assembly 13actions may be supported and augmented by this additional cuttingtransport assembly 102. In this configuration, the cutting beaks 13 maybe supported more firmly at their distal points and may be aided incoring by an additional forward-edge-sharpened surface 103 (distaledge), rotating and distally-moving component 101. In this illustration,a bearing surface rim 104 may be provided to protect the side edges ofthe rotating, cutting beak assembly 13.

FIGS. 20, 21 and 22 show in various perspective views, an alternateconfiguration with a single, hinged, rotating, cutting beak element 13,with an opposite fixed (non-hinged), rotating, cutting beak element 13b, according to still another embodiment. FIGS. 23 a and 23 b are sideviews of the single hinged rotating cutting beak 13 a and the fixedhinge rotating cutting beak 13 b shown in FIGS. 20-22. According to oneembodiment, the hinged cutting beak 13 a is shown fitted with a slidelocator hinge tab 105 at hinge assembly 106 (similar in location tohinge assembly 50 FIG. 14). The purpose of this slide locator hinge tab105 is to rotate inside core/transport outer tubular element 25 alongwith inner helical core/transporting component 26, yet enable axialmovement so as to close cutting beak element 13 b inwards towardscutting beak 13 a for the purposes of closed beak penetration, andparting off or severing a core sample at its base attachment point atthe end of the coring stage. As shown, the axially actuating slidelocator hinge tab 105 causes actuator rod 130 to interact with slideridge/rim 107, which may be connected to slide locator hinge tab 105. Asactuating rod 130 moves distally and proximally in an axial direction,its force may be transmitted via clevis 108, through slot in outertubular element 25, to the ridge/rim 107 which, in turn, moves slidelocator hinge tab 105 a corresponding distance and direction. Thisaction moves rotating beak 13 b about its other hinge pivots 109 onnon-hinged rotating beak 13 a, to oppose (close down upon) rotating beak13 a along its sides and front cutting edges for the purposes of closingthe end of coring and transport assembly 11 for penetration and/orparting off of a core sample at its base connection with host tissue.Also, beak tips 53 may be configured to work together in cutting actionby resting in closed position adjacent to each other (scissors actionwhen rotating), to meet at their tips only, or to assume an “overbite”,“underbite” or other configuration to assure positive part off of thetissue specimen to be collected for transport, regardless of whetherother adjacent beak edges completely touch along their entire border ornot.

Referring now to the mechanisms of actuation of the rotating, cuttingbeaks, FIG. 24 shows a driving motor/clutch assembly 29, a set of gearand crank/connecting rod assemblies 110, 111, as well as theirrelationships with outer tubular element 25 and transport elements 26(helix) and 27 (magazine) of tubular coring and transport assembly 11,according to one embodiment. These assemblies may be configured tosequentially and continuously actuate the outer tubular element 25 andtransport element 26 in rotation and axial movements. As shown in FIG.24, a large gear and connecting rod assembly 110 and 111 related to andacting on an inner non- or differentially rotating helical tubularcomponent 26 via a slide/ring/and/or gear component 116 may be provided,as well as a similar assembly 110 and 111 related to and acting on anon- or differentially rotating outer tubular element 25 via a similarslide/ring or gear assembly 117. In one embodiment, the gear andconnecting rod crank-type assemblies 110 and 111 may be configured tomove the outer tubular element 25 and transport element 26, themselvescomponents of the tubular coring and transport assembly 11, relative toone another such that, in turn, the outer tubular elements 25 andtransport element 26 individually act on the cutting beak assembly 13,FIG. 1, along the long axis of the biopsy device 10, to cause thecutting beak assembly 13 to open and close while rotating so that theymay be able to open widely within the tissue for coring and then at theend of the coring cycle close back down against one another to sever thebase attachment of the core sample. For illustration purposes, it isuseful to refer once again to the individual components as shown in FIG.14, including tubular non- or differentially rotating outer tubularelement 25, inner helical non- or differentially rotatingcoring/transport element 26 as well as cutting beak assembly 13. As isfurther shown in FIG. 24, the driving motor/clutch assembly 29 may becoupled, via gearing assemblies 112, to one or both of the outer tubularelements 25 and transport element 26, such as by a worm gear and bevelgear set as shown or by some other functionally equivalent assembly orassemblies, thus achieving matched or differential speeds of bothrotation and beak penetration/opening/closing, as desired. The purposeof such a mechanism as shown in this embodiment of FIG. 24, and alsoreferring to the elements 25, 26 and 13 in FIG. 14, may be to rotate oneor both of the outer tubular elements 25 and transport element 26, ineither the same or opposite directions, which then also rotate thecutting beak assembly 13 during the various phases of coring,part-off/sever the core sample (not shown) and transport the same backproximally through the handle 12, via the tubular coring and transportassembly 11, outer tubular element 25 and transport element 26 and/ormagazine element 27 at the junction 119 of elements 26 and 27 of thebiopsy device 10 and into a storage magazine 27 such as shown in FIGS.3. The worm gear element of gear assembly 112 may be divided into twosections with different pitch (not shown), for instance a pitchassociated with slide/ring component 116 (116 a) and a relativelydifferent pitch for slide/ring/or gear component 117, itself gear pitchmatched to its corresponding section 117 a of the worm gear. Such anarrangement would provide one means of differentially rotating outerelement 25 relative to the rotational speed of inner element 26. Afurther illustration shown in FIG. 24 refers to a vacuum/deliverymechanism (also designated element 140, FIG. 30 described below), whichmay comprise a syringe type component 113 and associatedcrank/connecting rod attachments 114 to one or more gears or othermechanisms (not shown) to drive a plunger assembly 115 back and forth tocreate positive pressure and/or vacuum, which may aid in coring andtransport. The vacuum/delivery component 113 may be coupled via, forexample, tube and valve assemblies (not shown) to a storage magazine 27such as shown in FIG. 2 for the purposes of augmenting core specimenmovement into a storage magazine 27, such as shown in FIG. 2.Additionally, a vacuum/delivery component may also be used to delivercomponents (not shown) to the biopsy site via the tubular coring andtransport assembly 11. A vacuum/delivery component may also be used todraw fluids and loose tissue cells from the target site (lesion or othersite) for collection and later cytologic analysis, such as shown in FIG.39, as discussed below.

Lastly in FIG. 24, a rack-and-pinion assembly may be provided, as shownat reference numeral 118 in FIG. 24. This rack-and-pinion mechanism maybe configured to move, as a unit, a carriage or sub-stage structure (notshown here) back and forth (distally and/or proximally) within andrelative to handle 12. This internal (to handle 12 of FIG. 1)sub-structure may contain as a unit, the assembly of componentsincluding driving motor assembly 29, as well as gearing assemblies 112,tubular elements 25 and transport element 26 of the tubular coring andtransport assembly 11 as well as the attached cutting beak assembly 13,and in one embodiment, vacuum/delivery components 113 and 114 and tissuespecimen storage magazine element(s) 27. An effect of such movementwould be to shorten or lengthen, such as distances 116 a, 117 a (notproportional to actual) the axial excursion of the coring components ofbiopsy device 10, during the coring/part-off phases, thus shortening orlengthening the core sample obtained, which in turn may lead to highercorrelation of sequential samples taken with the video imaging of theprocedure as well as the written record of sequential samples taken fromthe site. This mechanism may itself also be used as a simple, repetitivepenetration mode function of this device, where the operator desires topenetrate the tissue in either closed or open beak configuration, withor without rotation, and in short stages. Such use would allow for slowor deliberate, precisely staged tissue penetration to a target tissuesite, for instance when the device is rigidly locked to a stereotactictable. This mechanism may be powered by any means, including but notlimited to, user controlled electrical power, mechanical, or manual(operator power such as a finger/thumb slide lever). If poweredelectrically, provision for selectable excursion may be provided(mechanism not shown). Also shown in FIG. 24 is the telescopingrelationships at 119 between internal helical coring/transport element26 and outer tubular element 25, as well as with a section of a storagemagazine 27 (distal section of storage magazine 27 slid over element 26and entering element 25 represented by area 120). This arrangement maybe configured to provide a vacuum-tight connection all along area 120 sothat vacuum and/or delivery may be accomplished by vacuum/deliverycomponents such as components 113 and 114.

FIGS. 25, 26 and 27 illustrate stages of continuous movement of thepresent biopsy device 10, through stages of a coring biopsy sequence orcoring phase of an entire biopsy procedure, according to furtherembodiments. These continuous movements may, however, be interrupted byan operator such that biopsy device 10 pauses in one stage or another asdesired by the operator. Reasons for interruption may compriseprolonging a closed-beak configuration for purposes of penetrationthrough difficult tissue, such as may occur in more fibrous breasttissue 16 and/or target lesion 15 of FIG. 2, or in order to pursuecontinuing to collect the sample but at a different angle, or to collecta longer specimen than originally envisioned at the start of the cycle.Gears and connecting rods such as 110 and 111 of FIG. 24 may beconfigured to act sequentially and in continuous and/or interruptedfashion, upon coring/transport tube elements 25 and transport element 26(as illustrated in FIG. 16) individually such that axial movements ofcomponents such as 25 and transport element 26 of FIG. 16 will movecutting beak assembly 13 to open and close at the right moments toaccomplish the various coring/part-off and other stages.

FIG. 25 shows one such stage (stage 1), appropriate for closed beakpenetration through the tissue of an organ such as breast tissue 16 onthe approach to a target lesion 15, as shown in FIG. 2. FIG. 25, forillustration purposes, splits the gears and connecting rods such as 110and 111 of FIG. 24 into individual components, labeled as 121 and 122for gears 110 of FIG. 24 and connecting rods 120 and 123 for connectingrods 111 of FIG. 24 As further illustrated in FIG. 25, connecting rod120 may be driven by gear 121. Connecting rod 120 may be coupled, suchas by a slide/ring/gear assembly 117 FIG. 24, to tubular element 25 ofFIG. 24. Element 122 may be a gear or disc, for example. In either case,gear 122 may be similar to and may be coupled to gear 121, such as by asingle axle (not shown) coupled to both gear 121 and gear 122. Gear 122may have a connecting rod 123 coupled thereto, which may also be similarto connecting rod 120. However, connecting rod 123 may be coupled by aslide ring mechanism 116 to inner helical tubular element 26 of FIG. 24.For purposes of illustration of one embodiment of this device, eitherconnecting rod 120 or 123 of FIG. 25 may be further connected to rod 130of FIG. 23 a, 23 b or 28, as suggested by the extension of a connectingrod from gear element 110 (not labeled) to actuator rod 114 in FIG. 24,which actuates the vacuum assembly plunger 115, with an extensiondistally (not labeled) along the outer element 25 of FIG. 24 toeventually become rod 130 of FIG. 28 in one embodiment of this device.

As noted, gears 121 and 122 may be solidly coupled together (as thoughsuperposed one over the other). However, the radial positions alonggears 121 and 122 respectively, of connecting rods 120 and 123 may bepurposely located differently such that a lead-lag relationship resultsbetween the positions of connecting rods 120 and 123 as gears 121 and122 rotate in solid connection with one another. FIG. 25 shows therelationship between connecting rods 120 and 123 that results in closedbeak assembly 13 configuration as a result of the attachments ofconnecting rods 120 and 121 respectively with tubular elements 25 andtransport element 26 of FIG. 24, which may be coupled to cutting beakassembly 13 such as shown in FIG. 5. In this stage, connecting rod 120associated with gear 121, lagging behind connecting rod 123 around gear122 (assuming counter-clockwise rotation of both gears for illustrationpurposes), may be placed more distally with respect to handle 12 andwith respect to connecting rod 123. This relationship results in cuttingbeak assembly 13 assuming a closed position. The stage shown in FIG. 25would be useful for parting off or severing of the core sample at itsbase and would also be a useful stage, if interrupted, for closed beakassembly 13 rotation of tubular coring and transport assembly 11 andpenetration by biopsy device 10 through breast tissue 16 on the approachto a target lesion 15, as shown in FIG. 2.

FIG. 26 shows a stage (stage 2) that is next in sequence relative to thestage shown in FIG. 25. This stage begins as connecting rod 123, movingaround gear 122, positions itself more distally with respect toconnecting rod 120. This relationship results in the cutting beakassembly 13 opening to a wide-open configuration, which may beadvantageous for coring and/or delivery of, for example, markers ortherapeutic agents to the site. It should be noted that both connectingrods 120 and 123 advance distally during this stage. However, sinceconnecting rod 120 lags behind connecting rod 123, connecting rod 120 ismore proximally placed than connecting rod 123 throughout this stage.

FIG. 27 shows the next stage in sequence (stage 3), where, as connectingrod 120 reaches its most distal position, connecting rod 123 has alreadymoved back proximally on its journey towards its position in stage 1.The result of the more proximal position of connecting rod 123 withrespect to connecting rod 120 results in cutting beak assembly 13closing and remaining closed until connecting rods 120 and 123 changetheir relative positions with one another as they approach stage 1 onceagain (shown in FIG. 25). It is understood that the shapes of discs,which may act on connecting rods 120 and 123, attached to gears 121 and122 (gears may be round, however, discs attaching to the connecting rods120 and 123 may be of other shapes), be other than circular, such aselliptically shaped (not shown), so as to vary the time spent in thevarious stages and relationships between connecting rods 120 and 123.

FIG. 28 shows a side view comprising an additional rod element(s) 130designed to act upon the same hinge assembly area(s) 70 (FIG. 7), asacted upon by the inner helical coring/transport element 26 of FIG. 24,according to one embodiment. The rod element 130 may be configured tostrengthen (augment) or replace the axial action upon the cutting beakassembly 13 of the inner helical coring/transport element 26 of FIG. 24or rod 120 of FIG. 25, since the precision available from a solid rodsuch as element 130 may be more robust and exact compared with thatavailable with a helical component such as component 26 of FIG. 24.According to such an embodiment, rod element 130 may be actuated in amanner and through a mechanism that may be similar to that shown actingon inner helical coring/transport element 26 of FIG. 24, for thepurposes of moving the hinge assembly(ies) 70 of FIG. 7, of cutting beakassembly 13 of the present FIG. 28. FIG. 28 also shows by dotted lines amost proximal position of a proximal portion 131 of cutting beakassembly 13 in closed position. Rod element(s) 130 may control cuttingbeak assembly axial motions via a similar slide/ring arrangement (notshown in FIG. 28) as shown inside the handle such as slide/ring elements116 and 117, FIG. 24. FIG. 29 is a perspective view showing the sameelements, including rod element 130, as shown in FIG. 28. Also, it is tobe understood that if these control rods are outside the inner helicalelement, but inside the outer tubular element, that the action ofrotating the helical element with tissue sliding along the rods, whichrotate with the outer tubular element at a different speed or direction,may assist in transport of the tissue specimen obtained. It is alsopossible, if the outer tubular element is of a different cross sectionalshape than a circle, and for instance is a square, that the control rodscould nest in the inner corners along the length of the outer tubularelement. FIG. 30 is a side view of biopsy device 10, according to oneembodiment. Attention is directed to vacuum augmentation assembly 140 inparallel with coring/transport components 11 of FIG. 1 and FIG. 2 toillustrate that simultaneous movement of the vacuum/delivery assembly140 with those of components 11 may result in augmentation of coring andtransportation of biopsy specimens (not shown) into and within storagemagazine 27.

FIG. 31 is a top view, according to embodiments, of the biopsy device 10of FIG. 30 showing a belt pulley mechanism 141 for drivingvacuum/delivery assembly 140 such that continuous cycling ofvacuum/transport components is possible during activation of thesecomponents. FIG. 31 also shows additional structures of connection(s)142 between vacuum/delivery assembly 140 and a storage magazine 27.Storage magazine 27 may have an internal helical transport component(not shown) similar to and extending from the component 26 of FIG. 24 ofthe tubular coring and transport assembly 11 of FIG. 2. Storage magazine27 may also have fenestrations or openings 143 along its length, each ofoptionally varying and/or progressively varying dimensions for thepurposes of evenly and/or progressively distributing vacuum and/orpositive pressure for material handling of tissue specimens (not shown),such as for sequentially collecting and/or emptying tissue samples (notshown), and/or for delivery/deposit inside organs such as breast tissue16 of certain materials (not shown) such as marker implants; tracerelements; medications for pre-treatments, intra-procedure treatmentsand/or post-treatments; and the like. FIG. 31 also shows a partialsegment of an optional guiding element 144, such as a movable or fixedguiding wire or needle, which may temporarily occupy a longitudinallumen (such as along the inside of the helical coring/transport element26) in device 10, or may be placed adjacent to the central core ofbiopsy device 10 such as in a barrel and/or loop or series of loopspositioned along a line parallel to the central core of biopsy device 10(this position not shown). The guiding element 144 may comprise, forexample, a laser light directed along the path of the tubular coring andtransport assembly 11 of the biopsy device 10 or other visual guidingaid, rather than (or in addition to) a solid material such as a needleor wire. If the tubular coring and transport element is configured to bebendable, it could follow over such a needle or wire that may be rigidlycurved, for example, and prepositioned to follow a prescribed path tothe target tissue. Element 144 may also be a simple hollow tube (ratherthan a needle with a sharp tip), which tube may be stiff, flexible, orsegmentally flexible such as of plastic material coupled to varyingdurometer plastic material or metallic material, may have an a-traumatictip, and may be placed into the lesion prior to introduction of thedevice over this element, or alternatively, it may be placed through thedevice at a later stage, for the purpose for example, of enablingcontinued access to the site upon removal of the biopsy instrument. Thepurpose of this access could be to deliver medications, brachytherapy orother implantable items (temporary or permanent) at a later time or day,with the advantage that such access could continue well beyond the timewhen the more bulky biopsy instrument is removed. Such an element couldbe secured in place for example, under a sterile dressing for later onetime or repeated use. Elements 140 and 27 may be removable and/orreplaceable as desired, such as when storage capacity may be filled tomaximum, or to switch to a delivery cartridge (not shown) such as shownbelow (e.g., cartridge 214, FIG. 39).

FIG. 32 shows a side view of a gear drive mechanism 150, according toone embodiment, for rotating an internal helical coring/transportelement 26 of FIG. 24 covered by an non-rotating (for example) outertube 25, 25 b illustrates a protruding key-type element that would serveto lock the outer tube to the device housing, if, for example, the outertube happened to have a round cross-section. As shown, actuating rod(s)130 (FIG. 28) may be housed within the tube 25, which would also bedriven forward (distally) and back (proximally) with coring/transportelement 26 in order to move cutting beak assembly 13. Actuating rod(s)130 may also be placed externally to tube 25, with, for example, thebeak assembly 13 in a “more than fully open” or over center (i.e.,cutting tips coring a greater diameter of tissue than the outsidediameter of tube 25 with external rod(s) 130) configuration to allow theexternal rod(s) 130 to rotate with tube 25 without binding on tissuebeing penetrated axially. An attachment segment of a tissue storagemagazine 27 (FIG. 31) is also shown.

FIGS. 33, 34 and 35 are “down the barrel” perspectives of elements suchas a non- or differentially rotating inner helical coring/transportelement 26 along with outer non- or differentially rotating outertubular element 25, according to further embodiments. These figures showvarying configurations of rifling internal treatments 160 (lands, pits,grooves, raised or recessed features, and the like) or other physicaltreatments of the internal surface of the outer tubular element 25. Thetreatments such as surface treatments 160 may be configured to create aresistance to the twisting of core tissue specimen(s) such that rotationof either the outer tubular element 25 or the inner helicalcoring/transport element 26 would cause the core tissue specimen(s) tomove in an axial direction. Inner treatments 160 as shown may beconfigured, according to one embodiment, as rifling grooves cut into theinner wall of an outer coring/transport tubular element 25, or may bestructural ribs placed around the inside wall of tubular element 25.Additionally, or in place of the rifling grooves or other features,creating a roughened interior surface within the inner surface of thetubular element 25 in a geometrically favorable (continuous ordiscontinuous) way, or any another way of creating a higher frictioninterior surface relative to an inner helical component 26, may resultin similar desired longitudinal movement of tissue specimen(s) such asfrom target lesion 15, urging such severed tissue core in the proximaldirection within the coring/transport element 25. FIGS. 34 and 35 showother possible rifling treatment 160 configurations of internal wallfeatures of outer tubular element 25, according to further embodiments.As described, rotation of either element 25 or 26, or differentialrotation of these elements, results in the most optimal movement forces,partially depending on tissue characteristics and other factors. It isto be understood that the optimal configurations may be determinedexperimentally for various types of materials being transported by thesemechanisms.

FIG. 36 shows yet another embodiment, provided with (an) additionalinternal helix or helices 170 with (a) different pitch angle(s) withrespect to a more internal helical component 26. In this embodiment,helical element(s) 170 may be provided in addition to, or in place of,internal surface components and/or surface treatments such as surfacetreatments 160, or others that may be integral or solidly attached tocoring/transport tube element 25. Utilizing a different speed ordirection, or keeping one or the other helical component fixed inrotation, are exemplary actions that result in longitudinal or axialmovement (e.g. proximally-directed) of (e.g., tissue) materials thereinsuch as from target lesion 15. Additionally, this drawing illustratesthe potential for use of the additional helical element or elements toact in concert or at differential rotational speeds and/or rotationaldirection, coupled with sharpened tips or tip edges, which if rotated atthe same speed and direction, would assist tissue penetration.

FIG. 37 shows three views of biopsy device 10, the top and bottom ofwhich are side views and the center view thereof being a plan view, fromthe top looking down, illustrating further aspects of embodiments. Inthis illustration, an internal carriage structure 180 is shown withcarried components, including: tubular coring and transport assembly 11;cutting beak assembly 13 along with but not limited to, all neededand/or added elements for actuation, coring, transport andstorage/delivery that may be movable with respect to handle 12 and itsfixed activation switches (not shown); and power supply and wiringattachments (not shown) to same. In this embodiment, vacuum/deliveryassemblies 140 may be fixed, rather than moved by carriage 180. One ofthe mechanisms for moving carriage 180 is a manual slide lever element181 that may be used by an operator to move the carriage structure 180manually during coring such that either a longer or shorter corespecimen lengths 182, 183 may be retrieved as desired, or to preventundesired penetration by coring elements of the present biopsy deviceinto adjacent vulnerable structures, such as major blood vessels orother nearby organs. Alternatively, actuation of carriage 180 may becarried out via a motor, or via mechanically driven mechanisms such as arack-and-pinion mechanism (not shown), for movement of carriage 180,including the excursion and direction of carriage 180. These movementsmay easily be made operator pre-selectable, or selected in real-time(i.e., during the coring stage itself), as desired.

FIG. 38 shows a side and top view of biopsy device 10, according to oneembodiment, including a carriage inclusive of an alternative carriage190, which in this case may comprise vacuum/delivery assembly 140, 141in its frame, such that movement of carriage 190 would likewise altertheir axially-directed excursions.

FIG. 39 is a side view of a biopsy device 10, according to embodiments,provided with and coupled to a collection receptacle 210 with its sealcap 211 in place and connection tube 212 unattached. Collection tube 212may comprise a one-way valve 213 in place, and other structures designedto deliver liquids collected from the biopsy site into collectionreceptacle 210 without permitting fluids to be aspirated byvacuum/delivery assembly 140 by replacing filter valve 216. In thisembodiment, storage magazine 27 (shown in FIG. 31) has been replaced bydelivery cartridge 214 such that vacuum/delivery assembly 140 may bepositioned to deliver contents of cartridge 214, which may bepre-packaged within cartridge 214. A connection tube 215 may be providedconnected between vacuum/delivery assembly 140 and delivery cartridge214, and this connection tube is depicted with a one-way filter-valve216, acting as a delivery port to the device for addition of materialsdesired to be injected to the transversed tissue or in the biopsy site,opposite in functional direction compared with one-way valve 213, also,such that, for example, ambient air (optionally filtered) may be drawnin by vacuum/delivery assembly 140 to enable it to deliver contents ofdelivery cartridge 214 to coring and transport assembly 11 fordeposition into the biopsy cavity (not shown), or into the tissues nearto the area of the biopsy.

FIG. 40 is a side view of biopsy device 10, according to anotherembodiment, which may comprise a delivery syringe 220 connected to thebiopsy device 10, such that upon depression of plunger 221 into deliverysyringe 220, its contents may be delivered to coring and transportassembly 11 for delivery and deposition into or near the biopsy cavity,or, if pre-biopsy, into the tissues near the target lesion. In thisillustration, reversal of the direction of rotation of tubular coringand transport assembly 11, would result in delivery distally (out theend of) out of the device into the tissue delivery site within forexample the lesion or nearby breast tissues. The contents of deliverysyringe 220 may comprise a variety of materials, including:pre-treatment medications, agents or other deliverables, which may besolid, semi-solid, liquid and/or gaseous in nature, radioactive, and/orcombinations of these; implantable elements which may be inert forpurposes of cosmetic enhancement; and marking materials for referenceand other purposes. Not all of these types of elements are shown,however, solid or spongy, compressible-type pellets 222 with internalmarker elements represented by 223 are depicted pictorially in FIG. 40.

The following describes aspects of the present biopsy methods, accordingto embodiments. In particular, described hereunder is the manner inwhich the closed and open beak assembly configurations and stages may beused for specific purposes, enabled by the present biopsy device'sdesign, functionality and features. As described herein, the biopsydevice 10 may be used in either or both the open and/or closed beakconfigurations at various times during the biopsy procedure for purposesof tracking the tip of the biopsy device 10 to a target lesion withinthe patient's tissue. There are specific clinical situations where itmay be desirable to penetrate the tissue leading to a target in closedbeak assembly configuration as shown in FIGS. 7 and 23 b, or in openbeak assembly configuration as shown in FIGS. 9 and 23 b. A clinicalexample of the use of the closed beak assembly configurations of FIGS. 9and 23 b may comprise gently approaching target lesion 15 so thatultrasound guidance disturbance may be minimized. Note that in theclosed beak configuration, no biopsy core may be generated or cut alongthe access path to the target lesion 15. A clinical need may be met inanother situation whereby the target lesion may be approached in theopen beak configurations of FIGS. 9 and 23. The open beak configurationenables operator of biopsy device 10 to remove, for example, a core ofdensely fibrous tissue to permit easy passage and minimal trauma forsubsequent maneuvers of this device after an interruption or halt to theprocedure (re-insertion, for example), or for passage of relatedcatheters, devices and the like to and through the path created to thetarget area(s). The methods involved in utilizing these two distinctlydifferent configurations are enabled by the designs of the rotating,cutting beak assembly 13 themselves, as well as by the ability of thebiopsy device 10 to halt or interrupt stages prior to moving onward to asubsequent stage. In addition, embodiments enable de-coupling ofrotation of closed beaks with progression to next stage(s). This featureenables continuous transport (while operating in “interrupted” stageconfiguration), as well as continuous coring/transport, limited only bythe length of assembly 11 combined with the length of storage magazineelement, such that cores as long as several inches may be retrieved,where clinically useful. A clinical situation where this may bedesirable may comprise following a particular structure within thetissue, such as along the pathway of a diseased milk duct (not shown) inbreast tissue, for example.

The present biopsy method, according to one embodiment, may image organ(such as breast) tissue and may identify the target lesion. The skinsurface may be cleaned using known sterile techniques. The patient maythen be draped, and (e.g., local) anesthetics may be administered asneeded. Thereafter, the present biopsy device may be introduced througha small incision (e.g., a skin nick). The present biopsy device may thenbe placed in a penetration mode, with the distal beak 13 being either inthe closed or open beak configuration. If the present biopsy device iscaused to assume the closed beak configuration (rotation only stage atany desired speed, including zero), the distal beak 13 may then beadvanced through the tissue, aiming towards the target lesion, stoppingjust short of the nearest edge of the target lesion (e.g., 2-4 mm). Thepresent biopsy device may be caused to assume a closed or open-beakconfiguration at any time prior to the part-off stage. The physician maythen continue advancing the present biopsy device as desired tocontinuously core, starting and stopping coring activity(rotation/transport) to redirect tip, and/or continue coring activitywhile redirecting tip. The coring may continue to create a specimen aslong as desired. The part-off stage may then be carried out, and thecoring/transport/part-off cycle may be completed.

The remainder of the entire biopsy cycle may be carried out as describedabove, keeping in mind that the present biopsy device may be caused toassume the open and closed beak configurations at any time. Theabove-described configurations/modes may be interrupted or maintained asoften and/or as long as desired. For example, such modes may be employedas needed to follow (open beak coring/transport mode) a pathway ofabnormal tissue growth, such as may be found along a duct in tissue inbreast for example. The obtained information may be used in open beakconfiguration as a means to further correlate (and document suchcorrelation) that specific core samples analyzed by histopathologicalexam are matched to specific imaged abnormalities within target area(s),utilizing the automatic recording and preservation capability inherentin the storage magazine design and intended use thereof.

Described hereunder are methods of utilizing an embodiment of thepresent biopsy device's carriage movement functionality and structures.The carriage structures and functionality, whether manually actuated orpowered and whether used “on the fly” during the coring stage orpre-set, may be utilized to prevent unwanted distal penetration of thepresent biopsy device into nearby vulnerable structures. Embodiments ofthe present biopsy device fulfill another significant clinical need byutilizing, separately or in combination, the record keeping capabilityinherent in the structure of storage magazine 27 (see FIG. 3) and thestructure and functionality of the carriage movement(s) to uniquelyfurther characterize collected cores of, in this case, varying lengths,each of which may be unique to that specific core sample. This featureand/or combination of features enable(s) an operator of the presentdevice to “mark” special areas of interest for the histopathologist.This marking can also accomplished by the present biopsy device, forexample, by the injection of marker elements such as dyes, utilizingadditional marking cartridges at any time or times during the procedure.

Indeed, according to one embodiment, a biopsy method may compriseimaging the organ (such as the breast) tissue and identifying the targetlesion. The surface of the skin may be cleaned, using known steriletechniques. The patient may then be draped and then (e.g., local)anesthetics may then be delivered as needed. The distal beak 13 of thepresent biopsy may then be introduced through a small incision (e.g.,skin nick). The penetration mode may then be activated, in either aclosed or open beak configuration. If the closed beak configuration(rotation only stage) is employed, the distal tip beak 13 may then beadvanced, aiming towards target lesion and stopping just short of thenearest edge of the target lesion (e.g., 2-4 mm). The open beak stagemay be initiated at any time and interrupted prior to part-off stage.The present biopsy device may be further advanced as desired tocontinuously core, starting and stopping coring activity(rotation/transport) to redirect the distal beak 13, and/or continuecoring activity while redirecting the distal beak 13. The coring may becontinued to create as long a specimen as desired. The part-off stagemay then be enabled and the coring/transport/part-off cycle may becompleted. During the biopsy stage, carriage movements may be utilizedas desired to safely limit (e.g., shorten or lengthen) the excursion toprevent unwanted entry of instrument tip into nearby organs and/ortissues, and/or in order to remove longer core specimen(s) to obtainmore abnormal tissue, and/or for inclusion of elements of normal tissueon near or far edges of the target lesion. In either or both cases(longer/shorter specimen cores), the information obtained while carryingout carriage movements may be utilized to further characterize (anddocument such characterization) the tissue collected at unique lengths,thereby enabling histopathological analysis of each specimen to bepositively correlated with specific imaged areas within the targetlesion, utilizing the automatic recording and preservation capabilityinherent in the storage magazine design and intended use.

Further aspects of the use of the storage magazine 27 (shown in FIG. 3)are now described, such that various clinical needs may be fulfilled bypermitting the operator of the present biopsy device to inspect the coresamples more closely, and in some cases tactilely, without destroyingthe record keeping function of storage magazine 27, FIG. 3. Additionalmethod of ex-vivo imaging are also described, as are the samples in theorder in which they were received and stored within storage/recordkeeping storage magazine 27, according to still further embodiments.Since storage magazines, according to embodiments, may be configured tobe removable and/or replaceable at any time(s) during the procedure, thepresent biopsy device enables a variety of procedural methods to ensuewhich would not be possible, or at least would be impractical, withoutthe structures disclosed herein. For example, using the present biopsydevice, a clinician may segregate the contents of one storage magazinefrom the contents of another, additional storage magazine. The operatorof the present biopsy device may also have the ability to interruptcorning/transport/storage with another function of biopsy device, allthe while, at operator's discretion, keeping the present biopsy device'sshaft coring and transport assembly 11 in place, thus minimizing traumaassociated with repeated removal and insertion of these elements of thepresent biopsy device.

Indeed, according to one embodiment, a tissue biopsy method may compriseperforming coring/biopsy/transport cycles as described above.Thereafter, the procedure may be completed by removing the storagemagazine and/or proceeding to marking and/or treatment phases. Thestorage magazine may then be removed and, if desired, placed underX-Ray, magnetic resonance imaging and/or ultrasound transducer or highresolution digital camera if the storage magazine is made of atransparent material. The core tissue specimens may then beimaged/recorded. The magazine may then be placed in a deliveryreceptacle, sealed and delivered to a lab for further analysis, makingnote of core lengths and correlating with imaging record(s) in-situ andex-vivo. Upon removal of storage magazine from the present biopsydevice, the collected cores may then be visually inspected through thetransparent walls of the magazine. The magazine may then be split opento tactilely analyze the tissue specimens as desired. The magazine maythen be closed again, with the specimen therein. The magazine may thenbe deposited in a transport receptacle, sealed and delivered to a lab.

The storage magazine may then be replaced with additional empty storagemagazine(s) as needed to complete the biopsy procedure. Alternatively,other cartridges/magazines may be fitted to the present biopsy device todeliver medications, markers and/or tracer elements, therapeutic agents,or therapeutic and/or cosmetic implants to the biopsy site. Theprocedure may then be terminated or continued, such as would be the caseshould the practitioner desire to biopsy/core other nearby areas asdeemed clinically useful.

The present biopsy device may be formed of or comprise one or morebiocompatible materials such as, for example, stainless steel or otherbiocompatible alloys, and may be made of, comprise or be coated withpolymers and/or biopolymeric materials as needed to optimizefunction(s). For example, the cutting elements (such as the constituentelements of the beak assembly 13) may comprise or be made of hardenedalloys and may be additionally coated with a slippery material ormaterials to thereby optimize passage through living tissues of avariety of consistencies and frictions. Some of the components may bepurposely surface-treated differentially with respect to adjacentcomponents, as detailed herein in reference to the transporting tubularand storage components. The various gears may be made of any suitable,commercially available materials such as nylons, polymers such asmoldable plastics, and others. If used, the motor powering the variouspowered functions of the present biopsy device may be a commerciallyavailable electric DC motor. The handle of the present biopsy device maylikewise be made of or comprise inexpensive, injection-molded plastic orother suitable rigid, easily hand held strong and light-weight material.The handle may be configured in such a way as to make it easilyadaptable to one of any number of existing guiding platforms, such asstereotactic table stages. The materials used in the present biopsydevice may also be carefully selected from a ferro-magnetic standpoint,such that the present biopsy device maintains compatibility withmagnetic resonance imaging (MRI) equipment that is commonly used forbiopsy procedures. The vacuum delivery assembly components may comprisecommercially available syringes and tubing for connecting to the presentbiopsy device, along with readily available reed valves for switchingbetween suction and emptying of materials such as fluids which may besuctioned by the vacuum components. The fluids collected by theembodiments of the present biopsy device in this manner may then beejected into an additional external, yet portable, liquid storage vesselconnected to the tubing of the present biopsy device, for discarding orfor safe keeping for laboratory cellular analysis.

The power source may comprise an external commercially available AC toDC transformer approved for medical device use and plugged into theprovided socket in the present biopsy device, or may comprise anenclosed battery of any suitable and commercially available powersource. The battery may be of the one-time use disposable (andoptionally recyclable) variety, or may be of the rechargeable variety.

The cutting beak assembly of embodiments of the biopsy devices may beused, without alteration of their shape, attachment or any othermodification, to penetrate tissue on approach to a target lesion. Thecutting beak assembly may then be used to open and core the tissuespecimen, and to thereafter part-off the specimen at the end of thecoring stage. The beak assembly may also be used to help augmenttransport of the collected specimen. Having such multiple functionsintegrated in a single device saves valuable cross-sectional area, whichin turn creates a device that has a minimal outer diameter whileproviding the maximum diameter core sample. Maximizing the diameter ofthe core sample is believed to be significant from a clinicalstandpoint, since it has been demonstrated in multiple peer-reviewedjournals that larger diameter core specimens yield more accuratediagnoses. The clinical desire for large diameter core samples, however,must be balanced against the trauma associated with larger caliberdevices. Embodiments optimize the ratio so that the clinician can havethe best of both worlds. Advantageously, according to one embodiment,the internal helical transport system may be configured to augment thecoring function of the forward cutting beaks. The helical transportcoring elements may be configured to apply gentle, predictable tractionon the cored specimen, during and after coring, which permits pairingthe ideal speed of longitudinal excursion of the coring elements of thepresent biopsy device with the ideal speed of rotational movement of thesame elements. In this manner, the architecture of the collectedspecimen is less likely to be disrupted during transport. It has beenshown in peer-reviewed scientific articles that preserving tissuearchitecture (i.e., preserving the architecture of the tissue as it wasin vivo) to the extent possible leads to an easier and more accuratediagnosis. The present vacuum/delivery mechanism may be configured toenable the force of vacuum to be exerted directly to the coringtransport components, such that coring and transport of the specimen ishandled as delicately, yet as surely, as possible and comprisesnon-significantly dimension-increasing components such as progressivelysized fenestration features within collection magazine areas. If thepresent biopsy device were to rely solely on vacuum for tissuetransport, then vacuum artifact, which is a known and describedphenomenon associated with conventional biopsy devices, might be presentto a greater degree than is present (if at all) in embodiments describedherein. On the other hand, were embodiments of the present biopsy deviceto rely solely on a physical pushing or pulling mechanism to retrievecut specimen samples, crush artifact might be more prominent than isotherwise present when embodiments of the present biopsy device andmethods are used.

Turning now to yet further structures of embodiments, the carriageelement provides structure within the handle of the present biopsydevice for locating the various internal drive components, and gives theoperator the ability to move this carriage with its components as aunit, enabling the operator to advantageously vary the core length inreal time, (i.e., during the procedure), with a mechanical arrangementcoupled to the present biopsy device that may be selected to be poweredmanually or by an internal or external motor. The presence of a cut-offswitch enables the operator to selectively choose a continuous operationfunction, which permits rapid yet controllable repeatable biopsy cycles.By enabling such a functional option, procedure times can be minimized,which may be a potential advantage since tissue images may become moreobscure with increasing procedure times as fluids accumulate at thesite.

Embodiments are highly portable and require minimal supportingequipment, especially in battery-operated or mechanically-poweredembodiments. For mechanically-powered embodiments, one or more “wind-up”springs may provide the mechanical power required by the present biopsydevice. Advantageously, such embodiments may find widespread acceptanceand use throughout the world, particularly in the moreeconomically-disadvantaged areas where access to disposable batteriesmay be difficult, or where mains power may be unreliable. Manyconventional devices designed for the purpose of tissue biopsy need, bytheir design limitations, far more external supporting mechanisms, suchas external drive systems, external fluid management and tissuemanagement systems, as well as separate power and delivery systems, allof which may be built in features of the embodiments illustrated anddescribed herein.

The internal surface treatments of an outer rube and a hollow, helicalinner component, when acting in concert, move materials in a variety ofphase states along longitudinally without the need for complexcomponents that would otherwise contribute substantially to the outercaliber dimensions of the present biopsy device. Embodiments comprise ahollow helical transport mechanism that may be both strong and flexible,which continues to function even when distorted by bending. Conventionalbiopsy devices typically cease to function properly if distorted evenslightly. As such, the present biopsy device may be configured to definea curve along its longitudinal axis and would still function properly,with minimal modifications.

Advantageously, a biopsy and coring device, according to embodiments,comprises features configured to perform medical core biopsy proceduresor for harvesting tissue for other uses. These features comprisestructures configured for penetration, coring, part-off, transport andstorage of core specimens for medical purposes such as diagnosis andtreatment of a variety of diseases and abnormalities. Integral anddetachable components may be provided and configured to aspirate fluidsfor cellular analysis as well as deliver agents at various selectablestages of the procedure. The present biopsy device may be selectable forautomatic and/or semi-automatic function, may be used with or withoutimage guidance, and may be compatible with a variety of guidance imagingequipment such as ultrasound, magnetic resonance imaging and X-rayimaging. The present biopsy device may be configured to be disposableand/or recyclable, highly portable, and delivered for use in sterilepackaging, typical of medical devices having contact with internal bodystructures. The present biopsy device may be configured to be minimallyinvasive; may be configured to collect maximum diameter tissue specimencores in operator selectable lengths as gently as possible so as topreserve gross anatomic, cellular and sub-cellular architectures,thereby maintaining the integrity of the overall structures and makeupof the samples themselves as well as their relationships with comprisednormal adjacent segments of tissue in the core samples so thattransition areas can also be used for analysis; and may be configured todeliver the samples reliably to a storage receptacle for sequentialrecording and easy retrieval therefrom, so that the biopsy specimens canbe analyzed as accurately and easily as possible. As embodied herein,the present biopsy device comprises several features that may betherapeutic in nature, to be utilized at various stages along thediagnosis/treatment pathway.

Embodiments are not limited in their utility and applicability tobiopsy-related applications. For example, the hollow helical transportcomponent may be used in may commercial/industrial applications wherehandling a variety or single-type material(s) is/are desirable,potentially on a much larger scale than is the case in medical biopsyprocedures. Since the present devices can function around corners forexample, the present biopsy devices may be made far more compactly thanother linearly-configured devices made for the same or similar purposes.Embodiments may also reliably function to core and/or transport underextreme conditions that may be difficult to control such as shiftingsurroundings and other factors. It is to be noted, moreover, that thedistal tip and/or body of the present biopsy device may be configured tobe steerable without loss of functionality, which may have uses bothwithin and outside of the medical field. Additionally, the length of thebarrel assembly portion (including, for example, the tubular coring andtransport assembly 11) of embodiments of the present biopsy devices maybe configured to have most any length, and to have a variety of shapes,such that embodiments might find utility in remote applications, some ofwhich may require traversal of multiple curves, which may themselves befixed in nature or moving, again, without adversely affecting theperformance of the present biopsy device. It is to be noted thatindividual elements and sub-systems of embodiments have separate utilityand may advantageously be deployed in other devices configured for otherpurposes. Indeed, the depiction and description of the embodimentsherein is not meant to convey that such separate elements, sub-systems,assemblies and mechanisms do not have novelty and utility outside of thefield of medical biopsies. For example, elements such as the rotating,cutting elements of beak assembly may perform their intended function(s)without the other components described herein and should not be assumedto be dependent on some of the other features in order to function asintended.

While certain embodiments of the disclosure have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the disclosure. Indeed, the novelmethods, devices and systems described herein may be embodied in avariety of other forms. Furthermore, various omissions, substitutionsand changes in the form of the methods and systems described herein maybe made without departing from the spirit of the disclosure. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thedisclosure. For example, those skilled in the art will appreciate thatin various embodiments, the actual physical and logical structures maydiffer from those shown in the figures. Depending on the embodiment,certain steps described in the example above may be removed, others maybe added. Also, the features and attributes of the specific embodimentsdisclosed above may be combined in different ways to form additionalembodiments, all of which fall within the scope of the presentdisclosure. Although the present disclosure provides certain preferredembodiments and applications, other embodiments that are apparent tothose of ordinary skill in the art, including embodiments which do notprovide all of the features and advantages set forth herein, are alsowithin the scope of this disclosure. Accordingly, the scope of thepresent disclosure is intended to be defined only by reference to theappended claims.

1.-58. (canceled)
 59. A biopsy system, comprising: a hollow shaftcomprising an outer surface and an inner surface that defines alongitudinal lumen; a tissue cutting assembly coupled to a distal end ofthe shaft and configured to cut a specimen from tissue; a specimentransport assembly disposed at least partially within the longitudinallumen and configured to receive the cut specimen and to transport thespecimen in a proximal direction within the longitudinal lumen; and aremovable guiding element extending substantially parallel to thelongitudinal lumen.
 60. The biopsy system of claim 59, wherein theguiding element comprises one of a needle, a wire and a hollow tube. 61.(canceled)
 62. The biopsy system of claim 59, further comprising aplurality of guide loops coupled to the outer surface of the hollowshaft and wherein the removable guiding element extends through theplurality of guide loops.
 63. The biopsy device of claim 59, wherein theremovable guiding element extends at least partially through thelongitudinal lumen of the hollow shaft.
 64. The biopsy device of claim63, wherein the removable guiding element further extends through thetissue cutting assembly and emerges distally past the tissue cuttingassembly.
 65. The biopsy device of claim 59, wherein the removableguiding element comprises one of a visual guiding aid and a laser.66-93. (canceled)
 94. The biopsy device of claim 59, wherein thespecimen transport assembly comprises a helical element configured forrotation within the hollow shaft.
 95. The biopsy device of claim 94, andwherein the tissue cutting assembly comprises a beak assembly comprisinga first hinged beak element and a second hinged beak element that arecollectively configured to assume at least an open configuration and aclosed configuration and wherein the helical element is coupled to thebeak assembly.
 96. The biopsy device of claim 59, wherein the biopsysystem is further configured to advance over the removable guidingelement to a site where the specimen is to be cut.
 97. The biopsy deviceof claim 59, wherein the removable guiding element is at least one offlexible and segmentally flexible and configured to define a curve andwherein the biopsy system if further configured to advance over theremovable guiding element along the curve.
 98. A method of performing abiopsy in a patient, comprising: placing a removable guiding elementwithin the patient such that a distal end thereof is disposed near asite from which a tissue specimen is to be cut; introducing a biopsydevice in the patient over the removable guiding element, the biopsydevice comprising a hollow shaft configured to receive at least theremovable guiding element; a tissue cutting assembly; and a tissuespecimen transport assembly disposed at least partially within thehollow shaft; cutting the tissue specimen from the site using the tissuecutting assembly; transporting the cut tissue specimen within the hollowshaft using the tissue transport assembly; and removing the biopsydevice from the patient over the removable guiding element, leaving theremovable guiding element in place within the patient.
 99. The method ofclaim 98, wherein placing is carried out with the removable guidingelement comprising one of a needle, a wire and a hollow tube.
 100. Themethod of claim 98, wherein placing is carried out with the removableguiding element being one of flexible and segmentally flexible andconfigured to define a curve and wherein introducing is carried out withthe biopsy device being introduced in the patient and following thecurve to the site from which the tissue specimen is to be cut.
 101. Themethod of claim 98, wherein introducing comprises advancing the biopsydevice over the removable guiding element such that the removableguiding element extends at least partially through the hollow shaft.102. The method of claim 98, wherein introducing comprises advancing thebiopsy device over the removable guiding element such that the removableguiding element extends through the tissue cutting assembly and emergesdistally past the tissue cutting assembly.
 103. The method of claim 98,wherein the specimen transport assembly comprises a helical elementconfigured for rotation within the hollow shaft.
 104. The method ofclaim 98, and wherein introducing is carried out with the tissue cuttingassembly comprising a beak assembly comprising a first hinged beakelement and a second hinged beak element that are collectivelyconfigured to assume at least an open configuration and a closedconfiguration, the helical element being coupled to the beak assembly.105. The method of claim 98, further comprising introducing one of atherapeutic and a diagnostic device over the removable guiding element.106. The method of claim 98, further comprising removing the removableguiding element from the patient.
 107. A method of performing a biopsyin a patient, comprising: introducing a biopsy device in the patient,the biopsy device comprising a hollow shaft configured to receive atleast the removable guiding element; a tissue cutting assembly; and atissue specimen transport assembly disposed at least partially withinthe hollow shaft; cutting the tissue specimen from a site within thepatient using the tissue cutting assembly; transporting the cut tissuespecimen within the hollow shaft using the tissue transport assembly;and placing a removable guiding element within the hollow shaft andadvancing a distal tip of the guiding element past the tissue cuttingassembly to a position near the site from which the tissue specimen wascut; and removing the biopsy device from the patient over the removableguiding element, leaving the removable guiding element in place withinthe patient.
 108. The method of claim 107, wherein the removable guidingelement is hollow and wherein the method further comprises delivering anitem through the hollow tube to the patient.
 109. The method of claim108, wherein delivering is carried out with the item comprising at leastone of a marker, a tracer, a medication and a brachytherapy implantableitem.
 110. The method of claim 108, wherein the removable guidingelement is hollow and the method further comprises coupling a source ofvacuum to the removable guiding element.
 111. The method of claim 107,further comprising coupling a delivery syringe at least to the hollowtube and using the delivery syringe to deliver at least one of a solid,semi-solid, liquid and gaseous material to the patient.
 112. The methodof claim 111, wherein the delivered material comprises at least one of acosmetic enhancement material, a marking material and a radioactivematerial.